Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière

Ischemic Stroke Clinical Trial

— NERVAL  

Official title:

Cohorte de Maladies Neurovasculaires Prises en Charge à la Phase aiguë et Suivies à Lariboisière

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06026696
• Other study ID #: APHP221076
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2038

Study information

• Verified date: July 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Peggy Reiner, Dr
• Phone: +33149956525
• Email: peggy.reiner[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Neurovascular diseases can cause ischaemic or haemorrhagic strokes. While the most common, such as atherosclerosis are widely studied, others are less well known, such as arterial dissections or cerebral angiopathies. What's more, most studies are limited to a few years' follow-up and the longer-term evolution of patients is less well assessed. Patient follow-up data available in routine practice and specific enrollment through the headache emergencies of the Lariboisière neurovascular intensive care unit (USINV) could provide a particularly rich resource.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: September 2038
• Est. primary completion date: September 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Adult patients =18 years

2. Patients admitted to the Neurovascular Intensive Care Unit with acute cerebrovascular disease OR Patients managed for acute cerebrovascular pathology with or without stroke by the Lariboisière neurology team.

3. No opposition from the patient to the research and for patients under guardianship or guardianship or lack of capacity to object (severe impairment of cognitive functions, dementia, etc.), no opposition from the legal representative.

Exclusion Criteria:

1. Patient refusing to take part in the study or refusal by the legal representative in the case of patients under guardianship or curatorship

2. Patient suffering from a rare neurovascular disease and being followed at the "Centre de référence des maladies vasculaires rares du cerveau et de l'oeil" (CERVCO)

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke

Intervention

Other:
• follow-up
Long term follow-up

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of a vascular event	Vascular event is defined as : myocardial infarction, ischaemic or haemorrhagic stroke, recurrence of cerebrovascular disease, systemic embolism, congestive heart disease, vascular or non-vascular death during patient follow-up.	Up to 5 years
Secondary	Incidence of a vascular event	Vascular event is defined as : myocardial infarction, ischaemic or haemorrhagic stroke, recurrence of cerebrovascular disease, systemic embolism, congestive heart disease, vascular or non-vascular death during patient follow-up.	Up to 10 years
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 3 months
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 1 year
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 2 years
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 3 years
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 4 years
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 5 years
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 6 years
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 7 years
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 8 years
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 9 years
Secondary	Modified Rankin score	The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.	At 10 years
Secondary	Occurrence of intercurrent pathologies requiring specific treatment	Pathologies are defined as : anxiety-depressive disorder, dementia, comititude, neoplasia, venous thromboembolism, haemorrhage, systemic disease, respiratory insufficiency	Up to 10 years
Secondary	Obstetrical prognosis	Incidence of pregnancies, complications, delivery methods	Up to 10 years
Secondary	Incidence of death	Age and causes of death	Up to 10 years
Secondary	Prevalence of vascular risk factors	Medical history, LDL (Low Density Lipoprotein), Tobacco, Arterial pressure, HbA1C (glycated hemoglobin)	Up to 10 years
Secondary	Number of associated treatments	Description of the types of treatment used	Up to 10 years
Secondary	Number of adverse events	Evaluation of treatment tolerance	Up to 10 years
Secondary	Treatment adherence		Up to 10 years
Secondary	Incidence of headaches		Up to 10 years